Skip to main content
OpenTrials
Completed

NCT Number: NCT06415188

The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Child Behavior Acute Pain Anxiety Disorders Anxiety and Fear Behavior Mental Disorders Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Turkey (Türkiye)

About this study

Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For the Child;

Inclusion criteria

  • Being in the 3-6 age group,
  • At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
  • At least one invasive intervention in the treatment plan
  • To be able to understand and speak Turkish
  • Staying in a room with at least two beds

Exclusion criteria

  • Having a neurological disorder
  • Not having a parent as a companion
  • Receiving oral treatment only
  • Hearing and vision problems
  • Single bed capacity room or isolated room

For the Parent

Inclusion criteria

  • Staying with their child as a constant companion
  • To be able to understand and speak Turkish
  • Accepting to participate in the study

The exclusion criteria:

  • Not staying with your child all the time

Treatment and study plan

Video game with headset

Behavioral

Half an hour before the first treatment in the morning, the screens around the patients' beds were closed by the researcher. The child was asked to choose one of the introduced games and the game he/she chose from the tablet was turned on. Children were asked to wear headphones for sound isolation and the sound was adjusted at the appropriate decibel setting. Half an hour before the treatment, children were allowed to play the video game until the treatment without any different warning. Physiologic Parameter Assessment Form, Child Anxiety and Fear Scale, Child Pain Scale were filled by the researcher 1 minute before and 1 minute after the procedure. Finally, Parental Satisfaction Scale was completed at the end of the intervention.

Primary outcomes

  1. Descriptive Characteristics Information Form

    Time frame: First measurement: 30 minute before treatment

    A descriptive characteristics information form for parents and children was prepared by the researchers in line with the literature and the data of both the experimental and control groups were collected before the intervention.

  2. Physiological Parameter Monitoring Form

    Time frame: First measurement: 1 minute before treatment

    The descriptive characteristics form was based on a literature review by the investigator. Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured 1 minute before treatment administration.

  3. Children's State Anxiety and Children's Fear Scale

    Time frame: First measurement: 1 minute before treatment

    Children's State Anxiety and Children's Fear Scale was developed by McMurtry et al. in 2011. The scale was designed to measure the fear levels of children aged 4-10 years. The scale was translated into Turkish by Gerçeker et al. in 2018 and the validity-reliability coefficient was found to be 0.89. The scale score is formed by scoring five drawn facial expressions (0=no fear to 4=severe fear) shown visually to the child. Anxiety and fear scores of the child were scored one minute before the treatment.

  4. Visual Analog Scale

    Time frame: First measurement: 1 minute before treatment

    Visual Analog Scale (VAS) was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by scoring with facial expressions. It is used in children who have the ability to communicate and are conscious. The scale has 6 faces that are scored between 0 and 5. In scoring, the child chooses the face that best expresses him/her and "0" indicates no pain, "1" indicates a little pain, "2" indicates a little more pain, "3" indicates more pain, "4" indicates quite a lot of pain and "5" indicates the most severe pain level. One minute before the treatment, the child's pain is scored by VAS.

  5. PedsQL Health Care Satisfaction Scale

    Time frame: First measurement: After treatment

    The PedsQL Health Care Satisfaction Scale was developed by J.W. Varni in 1999. Turkish adaptation of the scale was conducted by Ulus and Kublay in 2012. The scale consists of 25 items with 6 subheadings: emotional support, information, general satisfaction, communication, family involvement and technical skills. The scale is on a five-point scale and each item is rated on a scale of 0 to 4 and is evaluated as "Never satisfied (0)", "Sometimes satisfied (1)", "Most of the time satisfied (2)", "Almost always satisfied (3)" and "Always satisfied (4)". A high score indicates an increase in parental satisfaction.

Secondary outcomes

  1. Physiological Parameter Monitoring Form

    Time frame: Second measurement: 1 minute after treatment

    Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured one minute after treatment administration.

  2. Children's State Anxiety and Children's Fear Scale

    Time frame: Second measurement: 1 minute after treatment

    1 minute after the treatment, the child's anxiety and fear score was scored again.

  3. Visual Analog Scale

    Time frame: Second measurement: 1 minute after treatment

    One minute after the treatment, the child's pain score was scored again

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Effect of Therapeutic Play on Pre-Treatment Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.